1. Daniel S. Hagg, MD January 15, 2016 Sepsis Care and the New Core Measures

2. Outline What is sepsis? A brief history of sepsis care How should we take care of septic patients now? Core measures What strategies work? Advice for small hospitals

3. Bacteria in the Blood Sepsis is NOT Sepsis IS The inflammatory response to infection

4. Sepsis is a major clinical problem DISEASENUMBER OF DEATHS/YEAR Severe Sepsis (Angus, 2001)215,000 AMI (Minino, 2002)193,000 Lung Cancer (Minino, 2002)156,000 Colon Cancer (Minino, 2002)57,000 Breast Cancer (Minino, 2002)42,000 Minino AM, Arias E, Kochanek KD, et al. Deaths: final data for 2000. National Vital Statistics Reports Web Site.

5. A patient presenting with severe sepsis has a mortality risk 6-10 times greater than AMI 4-5 times greater than stroke

6. Diagnosis Terms to foster common dialogue

7. Diagnosis Sepsis = Systemic Inflammatory Response Syndrome (SIRS) plus suspected infection Sepsis ≠ hypotension

8. First some definitions (you can’t treat what you don’t recognize) What is “SIRS”? Systemic inflammatory response syndrome What is “sepsis?” Severity of sepsis? (and why it matters) Sepsis Severe sepsis20-35% mortality Septic shock30-70% mortality SIRS criteria (need ≥ 2 out of 4) Temp >38.3C or < 36C HR > 90 bpm RR >20/min or pCO 2 <32 mmHg WBC 12000, or >10% bands SEPSIS is a MEDICAL EMERGENCY SIRS and a SUSPECTED infection

9. More definitions What is “severe sepsis?” Evidence of sepsis-induced tissue hypoperfusion or organ dysfunction: Hypotension Elevated lactate > 4 Urine output 2hr Acute hypoxemia (P:F ratio < 300) Altered mental status Cr >2 mg/dL Bilirubin >2mg/dL Platelet 1.5 Paralytic ileus What is “septic shock?” Severe sepsis = sepsis + any end organ damage (mortality 20-35%) Septic shock = severe sepsis + need for vasopressors despite fluid resuscitation (mortality 30-70%)

10. Progressive Mortality can be reversed SIRS

11. Date of download: 7/22/2014 Copyright © 2014 American Medical Association. All rights reserved. From: Mortality Related to Severe Sepsis and Septic Shock Among Critically Ill Patients in Australia and New Zealand, 2000-2012 JAMA. 2014;311(13):1308-1316. doi:10.1001/jama.2014.2637 Mean Annual Mortality in Patients With Severe SepsisError bars indicate 95% CI. Figure Legend :

12. Date of download: 7/22/2014 Copyright © 2014 American Medical Association. All rights reserved. From: Mortality Related to Severe Sepsis and Septic Shock Among Critically Ill Patients in Australia and New Zealand, 2000-2012 JAMA. 2014;311(13):1308-1316. doi:10.1001/jama.2014.2637 Adjusted Annual Odds for the Change in Hospital Outcomes Reported as Odds Ratios Referenced Against the Year 2000When considered as a continuous variable, there was no difference between patients with severe sepsis or septic shock and other patients in the database for the decline in mortality over time (odds ratio [OR], 0.94 [95% CI, 0.94-0.95] vs 0.94 [95% CI, 0.94-0.94]; P =.37), whereas significant differences were observed in the change over time for discharge to home (OR, 1.03 [95% CI, 1.02-1.03] vs 1.01 [95% CI, 1.01-1.01]; P <.001) and discharge to rehabilitation facilities (OR, 1.08 [95% CI, 1.07-1.09] vs 1.09 [95% CI, 1.09-1.10]; P <.001). Discharge to rehabilitation included discharge to rehabilitation facilities and chronic care facilities such as nursing homes. ICU indicates intensive care unit. Figure Legend :

13. How did we do it? Randomized trial of usual care v. early goal directed therapy 263 patients 16% Absolute risk reduction in mortality

14. Goal Directed therapy 1.Recognize sepsis (give fluid bolus) 2.Administer fluids to goal CVP 3.Give vasopressors to target MAP 4.Check ScVO2 and treat accordingly 1.low with normal Hgb, give dobutamine 2.low with low hgb, give blood

15. Early therapy reduces mortality ARR: 46.5 – 30.5 = 16%. Therefore NNT: 1/ARR or 1/0.16 = 6.25

16. Comparisons in EGDT vs. Controls

17. Hospital costs decrease 22.9% $2,749 - $7019 per QALY Implementation and effectiveness analysis

18. Survivorship has substantially increased

20. But now I’m told goal-directed therapy is dead

22. ProCESS Trial Objectives Study EGDT in multi-center format Compare 3 protocols Wild-type resuscitation Protocol guided standard care Protocol guided EGDT

23. Interventions

24. Important Highlights

25. Outcomes

29. What is important All of these patients received fluids equivalent to Rivers et al EGDT 97%+ antibiotics within 6 hours >70% received antibiotics prior to enrollment All “identified” as sepsis

30. Editorial

31. What should we do now? Our best recommendations are those of the core measures However, everything starts with EARLY recognition and a sense of medical emergency

32. Identifying those at risk and making early diagnosis

33. Be suspicious….. The key trait for making early diagnosis is having a constantly elevated index of suspicion Physicians need to look for sepsis in the same way they look for stroke or AMI, in fact, it is probably more important

34. Some thoughts on early diagnosis

35. A role for lactate? ED at Beth Israel Hospital in Boston 1287 patients with lactates drawn

36. Lactate up = higher mortality

37. More on Lactate

38. Blood pressure changes?

39. Isolated low BP? 4700 consecutive ED admissions screened for any episode of low BP 887 cases found

40. Episodes of hypotension

41. Core Measures In development since before 2007 Extremely complicated measures “specifications manual” = 63 pages long! labelled as SEP-1

46. Strategies Create a culture of passion for the care of septic patients Become an evangelist! Take every moment to coach up the team Sepsis care is a TEAM effort Teach away medical mythology create pathways and order sets that leverage current practices in other areas into best sepsis care

47. Common Myths 1.Avoiding Fluids in certain patient populations 1.Renal failure 2.Heart failure 2.Giving Normal Saline because the potassium is high 3.There is a “maximum” vasopressor dose 4.We give fluids to raise the blood pressure

48. Myth #1 I am commonly told that people “didn’t want to give too much fluid” due to either heart failure or renal failure The 30cc/kg bolus septic patients need is well tolerated by almost everyone. Avoiding sufficient fluids is practicing as per the control group in Dr. Rivers goal-directed trial Sepsis associated renal failure is much harder to reverse if we fail to restore perfusion

49. Myth #2 It is common to avoid Lactated Ringer’s if there is acute kidney injury or elevated potassium due to potassium content There is only 4mEq/L of potassium LR is a neutral pH buffered solution vs. NS that has a pH of 4.5 and causes a hyperchloremic acidosis Most hyperkalemia is due to acidosis related cellular shifts. correcting the acidosis fixes the hyperkalemia.

50. Myth #3 The patient is on “max” norepi There is simply no such thing. They need what they need. I have used doses as high as 4mkg/kg/min (>400mkg/min) in patients who survive.

51. Myth # 4 Fluids are given to raise the blood pressure Fact: fluids fill the ventricles and improve stroke volume/cardiac output. If cardiac output doesn’t increase with fluid, the patient will NOT benefit from more fluid. Use vasopressors.

52. Straight leg raise

56. Antibiotics

57. Retrospective data collection at 22 centers All patients with sepsis Evaluated appropriate abx by whether it fit guidelines or covered eventual cultures

58. Outcomes

59. Summary Sepsis is a MEDICAL EMERGENCY Sepsis care has evolved substantially over 15 years with significantly reduced mortality The core of sepsis care is: Early diagnosis Early fluids Early antibiotics The new core measures reflect these data

60. Advice Find committed and motivated people Give them the time, tools and authority to work on this system Support the message every day Be prepared for this to take a long time Daniel S. Hagg Assistant Professor, Director of MICU Director of Inpatient Quality for the Department of Medicine Oregon Health and Sciences University 503-494-6668 or Cell 503-228-0459 haggda@ohsu.edu